Merit Medical releases 24-month efficacy results from AVF arm of WAVE trial

Merit Medical (MMSI) Systems announced positive findings from the randomized AVF arm of the WAVE trial. These findings were presented during the Late-Breaking Clinical Trials session on Tuesday, November 4, 2025, at the Vascular Interventional Advances conference held in Las Vegas, Nevada. The WAVE trial was designed to capture the performance of the WRAPSODY CIE. TLPP and ACPP outcomes were used to evaluate the ability of the device to restore functional vascular access in trial patients. Forty-three centers across the United States, South America, and the United Kingdom participated in the trial. In the randomized arm of the WAVE trial, 245 hemodialysis patients with evidence of venous obstructions in their AVF were treated with either the WRAPSODY CIE or PTA. Twenty-four months following treatment, TLPP was significantly higher among patients treated with the WRAPSODY CIE versus PTA. Similarly, the ACPP was significantly higher among patients treated with the WRAPSODY CIE versus PTA. These findings align with the significant clinical benefits demonstrated at 6 months and 12 months.